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ClinicalTrials.gov Identifier: NCT00880165

Recruitment Status :
Completed

First Posted : April 13, 2009

Results First Posted : April 21, 2014

Last Update Posted : April 21, 2014

Sponsor:

US Department of Veterans Affairs

Collaborator:

Leonard Davis Institute of Health Economics

Information provided by (Responsible Party):

VA Office of Research and Development ( US Department of Veterans Affairs )

Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure.

Home unattended testing

Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure.

Total of all reporting groups

Overall Number of Baseline Participants

148

148

296

Baseline Analysis Population Description

...

Baseline Analysis Population Description

Veterans referred to the participating sleep centers for evaluation of obstructive sleep apnea

Age, Continuous

Mean (Standard Deviation)

Unit of measure: Years

Number Analyzed

148 participants

148 participants

296 participants

51.8
(10.4)

55.1
(10.3)

53.2
(10.4)

Age, Categorical

Measure Type: Count of Participants

Unit of measure: Participants

Number Analyzed

148 participants

148 participants

296 participants

<=18 years

0

0.0%

0

0.0%

0

0.0%

Between 18 and 65 years

137

92.6%

135

91.2%

272

91.9%

>=65 years

11

7.4%

13

8.8%

24

8.1%

Sex: Female, Male

Measure Type: Count of Participants

Unit of measure: Participants

Number Analyzed

148 participants

148 participants

296 participants

Female

10

6.8%

13

8.8%

23

7.8%

Male

138

93.2%

135

91.2%

273

92.2%

Region of Enrollment

Measure Type: Number

Unit of measure: Participants

United States

Number Analyzed

148 participants

148 participants

296 participants

148

148

296

Functional Outcome of Sleep Questionnaire
[1]

Mean (Standard Deviation)

Unit of measure: Units on a scale

Number Analyzed

148 participants

148 participants

296 participants

14.7
(2.9)

15.0
(3.2)

14.9
(3.0)

[1]

Measure Description: Self-administered validated questionnaire assessing functional outcomes in patients with obstructive sleep apnea. The FOSQ total score range is from 1 to 20 with higher scores indicating better functional outcome. The FOSQ has 5 subscale scores: activity level, vigilance, intimacy and sexual relationships, general productivity, social outcome, The range of subscale scores is from 1 to 4 with higher scores indicating better function. The total score is calculated as the mean of the subscales multiplied by 5.

VA sleep-study and treatment medical service use will be derived from ...

Description

VA sleep-study and treatment medical service use will be derived from the case report form; and costed out using VA acquisition costs. Other medical service use will be derived from VA administrative records. Non-VA medical service use will be derived from patient interview and will be costed out using federal reimbursement schedules. Costs will be stratified by whether or not they are related to the diagnosis and treatment of OSA.Cost and preferences are assessed for each entire arm.

Time Frame

Medical service use and cost will be collected every 3 months for the entire observation period. Thus the shortest duration of follow-up in the study is anticipated to be 3 months, while the longest will be 2.25 years.

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Participants diagnosed with obstructive sleep apnea who were prescribed continuous positive airway pressure (CPAP) treatment. Of the 148 individuals randomized to each arm, 110 in the in-lab testing arm and 113 in the home testing arm were prescribed CPAP. Results from these 223 subjects were used in the per protocol analysis.

Arm/Group Title

Arm 1

Arm 2

Arm/Group Description:

In-laboratory testing
...

Home unattended testing
...

Arm/Group Description:

In-laboratory testing

Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure.

Home unattended testing

Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure.

Participants diagnosed with obstructive sleep apnea who were prescribed continuous positive airway pressure (CPAP) treatment. Of the 148 individuals randomized to each arm, 110 in the in-lab testing arm and 113 in the home testing arm were prescribed CPAP. Results from these 223 subjects were used in the per protocol analysis.

Arm/Group Title

Arm 1

Arm 2

Arm/Group Description:

In-laboratory testing
...

Home unattended testing
...

Arm/Group Description:

In-laboratory testing

Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure.

Home unattended testing

Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure.

Overall Number of Participants Analyzed

110

113

Mean (Standard Deviation)

Unit of Measure: units on a scale

1.85
(2.46)

1.74
(2.81)

3.Secondary Outcome

Title

Continuous Positive Airway Pressure Adherence

Description

Mean daily hours of use of continuous positive airway pressure over th...

Description

Mean daily hours of use of continuous positive airway pressure over the 3 month intervention

Time Frame

3 months

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Participants diagnosed with obstructive sleep apnea who were prescribed continuous positive airway pressure (CPAP) treatment. Of the 148 individuals randomized to each arm, 110 in the in-lab testing arm and 113 in the home testing arm were prescribed CPAP. Results from these 223 subjects were used in the per protocol analysis.

Arm/Group Title

Arm 1

Arm 2

Arm/Group Description:

In-laboratory testing
...

Home unattended testing
...

Arm/Group Description:

In-laboratory testing

Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure.

Home unattended testing

Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure.

Adverse events were collected every 3 months for the entire observation period. Collection of adverse events occurred over 2.25 years in the first enrolled participant and over 3 months in the last enrolled participant.

Adverse Event Reporting Description

[Not Specified]

Arm/Group Title

Arm 1

Arm 2

Arm/Group Description

In-laboratory testing
...

Home unattended testing
...

Arm/Group Description

In-laboratory testing

Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure.

Home unattended testing

Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure.

All-Cause Mortality

Arm 1

Arm 2

Affected / at Risk (%)

Affected / at Risk (%)

Total

--/--

--/--

Serious Adverse Events Serious Adverse Events

Arm 1

Arm 2

Affected / at Risk (%)

Affected / at Risk (%)

Total

0/148 (0.00%)

0/148 (0.00%)

Other (Not Including Serious) Adverse Events Other (Not Including Serious) Adverse Events